# Combination of Novel Therapies for CKD Comorbid Depression (CONCORD)

> **NIH NIH R01** · UT SOUTHWESTERN MEDICAL CENTER · 2021 · $696,929

## Abstract

Project Abstract
The overall goal of our research is to determine whether treatment of a Major Depressive Disorder (MDD)
improves the outcomes of patients with chronic kidney disease (CKD). We showed that MDD is present in up to
25% of CKD patients and independently associated with progression of CKD to End-Stage Kidney Disease,
hospitalization, and death. Depression was also shown to be associated with adverse patient-centered outcomes
such as lower quality of life (QOL), fatigue, poor sleep, and non-adherence to diet and medications. However,
evidence for efficacy and tolerability of commonly-used antidepressant medications or nonpharmacologic
treatments are very limited in CKD patients. Previous data, primarily derived from dialysis-dependent patients,
were limited by small samples, lack of randomization and control, short durations, and high dropout rates. Our
group was the first to conduct a double-blind randomized controlled trial for MDD treatment in 201 patients with
non-dialysis CKD, and showed that sertraline, a commonly used selective serotonin reuptake inhibitor (SSRI),
was no more efficacious than placebo for improving depressive symptoms. Given the high prevalence of MDD
in CKD, its association with adverse outcomes, and lack of data to support efficacy of conventional
treatments, it becomes imperative to test novel strategies to treat MDD in CKD patients. We propose to
compare with a control group, the efficacy and tolerability of two novel treatment strategies - (1) Behavioral
Activation Teletherapy (BAT) for 16 weeks, with the addition of bupropion, a non-SSRI antidepressant, at 8
weeks for patients whose depression has not remitted (non-remitters); and (2) bupropion for 16 weeks, with the
addition of BAT at 8 weeks for non-remitters. In Aim 1, we will investigate the efficacy and tolerability of these 2
strategies vs. control for improvement in a primary endpoint of depressive symptoms in 201 patients (67 per
group) with non-dialysis CKD stages 3b-5 and MDD at 2 sites, randomized 1:1:1 to either strategy or a control
group of Clinical Management plus placebo. We hypothesize that either approach vs. control will result in a
minimal clinically important difference of 2 points improvement in depressive symptoms, as ascertained blindly
by the Quick Inventory of Depressive Symptomatology. In Aim 2 we will investigate the efficacy and tolerability
of 8 weeks of (1) single-blind BAT plus placebo or (2) double-blind bupropion plus Clinical Management vs.
control for improvement in depressive symptoms. In Aim 3, we will compare the efficacy of these 2 treatments
strategies vs. control for improvement in CKD patient-centered outcomes including a. adherence to medications
and healthcare visits; b. fatigue; c. sleep; and d. overall functioning. A clinical trial is urgently needed to address
the evidence gap that exists for MDD treatment in CKD patients. Establishing the efficacy of 2 different strategies
would be imperative, so that if foun...

## Key facts

- **NIH application ID:** 10145674
- **Project number:** 5R01DK124379-02
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** Susan Hedayati
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $696,929
- **Award type:** 5
- **Project period:** 2020-04-15 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10145674

## Citation

> US National Institutes of Health, RePORTER application 10145674, Combination of Novel Therapies for CKD Comorbid Depression (CONCORD) (5R01DK124379-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10145674. Licensed CC0.

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